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Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Routin SA
ClinicalTrials.gov Identifier:
NCT00717912
First received: July 16, 2008
Last updated: July 12, 2017
Last verified: July 2017
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Healthy Volunteers
Interventions: Other: Experimental sweetener syrup
Other: Classical sweetener syrup
Other: Classical sugar syrup

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1 Classical sugar syrup/ Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup
Arm 2 Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Experimental sweetener syrup
Arm 3 Experimental sweetener syrup / Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup / Experimental sweetener syrup
Arm 4 Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup / Classical sugar syrup / Classical sweetener syrup
Arm 5 Classical sugar syrup / Experimental sweetener syrup / Classical sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sugar syrup
Arm 6 Experimental sweetener syrup / Experimental sweetener syrup / Experimental sweetener syrup / Classical sugar syrup / Classical sweetener syrup / Classical sugar syrup / Classical sugar syrup

Participant Flow:   Overall Study
    Arm 1   Arm 2   Arm 3   Arm 4   Arm 5   Arm 6
STARTED   1   1   1   1   1   1 
COMPLETED   1   1   1   1   1   1 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants Each subject received the study products in different order according to the randomization list

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.7  (4.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      6 100.0% 
Region of Enrollment 
[Units: Participants]
 
France   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycemic Index   [ Time Frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge ]

2.  Secondary:   Insulinemic Index   [ Time Frame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Doctor
Organization: Biofortis
phone: 0240205799
e-mail: info@mxns.com



Responsible Party: Routin SA
ClinicalTrials.gov Identifier: NCT00717912     History of Changes
Other Study ID Numbers: SIRODEX 9708
Study First Received: July 16, 2008
Results First Received: November 29, 2012
Last Updated: July 12, 2017